Generic Drugs in India

The Novartis Patent Case

As the Times of India reports, India started granting product patents on medicines in 2005 with one striking proviso.  New forms or variations of known substances could not fall under the patent umbrella unless they exhibited “enhanced efficacy”, terminology which has troubled foreign pharmaceutical firms.  Section 3(d) of the Indian patent law is the magic provision that distinguishes India from the United States and the European Union in approaches to how those patents are to be determined.  It also allows, much to the worry of pharmaceutical giants, standing to public interest groups to object to the grant of a patent.

It is for that reason that the Swiss company was refused a patent for the beta-crystalline form of imatinib mesylate, a drug used in the treatment of chronic myeloid leukaemia (CML).  Novartis’ history with getting a patent in India on this drug is extensive, with an application for a patent filed as far back as 1998.  After the passage of the legislation in 2005, the CPAA (Cancer Patients Aid Association) filed its opposition to the grant of a patent, citing the relatively high price Novartis was setting for its version of the drug (Glivec) at 130,000 rupees ($2400) a month against the considerably cheaper 8000 to 12000 rupees a month.  The opposition did its trick, and Novartis’ patent application was refused by the Patent Office.

This was merely the start of a long road along Indian legal bureaucracy.  The Madras High Court rejected a challenge to the term “efficacy” in section 3(d) as too vague.  The Intellectual Property Appellate Board (IPAB) in turn rejected Novartis’ appeal against the rejection of its patent application in 2009.  All of this culminated in a final appeal to the Indian Supreme Court, which in turn rejected arguments by Novartis that the section be interpreted liberally to allow a patent on imatinib mesylate as being therapeutically efficacious.

The judges of the Supreme Court found that the company had not made the case for such efficacy, certainly not in the “therapeutic” sense.  Benefits after using the drug in some patients were not a sufficient standard.  Furthermore, the applicants for such a patent needed to show that efficacy based on research conducted on living animals.

One should resist the temptation to see the entire pharmaceutical industry as a ruthless band of mercenaries intent on placing peoples’ lives before affordable treatment. The entire market has, in a sense, been shaped around a tense and dangerous contradiction.  To succeed in that market, the companies need to make returns for investors who are bound to turn away from portfolios that do not make them.  A cut throat incentive is oddly coupled with the desire to sell drugs that work; the profit motive takes up arms against the therapeutic motive.

Novartis’ website, in describing the Glivec case, features a draped Indian lady forlorn in appearance with the statement of purpose from the company: “We are committed to provide access to medicine for patients worldwide.”  But how is this possible where the sick find the drugs prohibitively expensive?  A glaring conflict of interest arises between market forces and dividend hunters, and those keen on seeing the lot of human health improved.  Such a conflict, in a sense, is dealt with by s. 3(d) but it is hardly going to be sending the pharma lobbies into enthusiastic fits wishing to invest in India.  India remains one of the world’s largest producers of generic drugs, a mantle it is keen to protect.

The case certainly has broader implications.  One is the consequences on investment in India from big pharmaceutical companies concerned that their applications for patents on drugs deemed generic in the Indian market.  Novartis said on April 1 that it will introduce new products into the Indian market but refuse to invest in research and development of medicines there.

The statement from Novartis (April 1), takes aim at the Supreme Court decision, asserting that the decision “clarifies limited intellectual property protection and discourages future innovation in India.”  Novartis insists on taking the moral high ground – the decision refuses to recognise “Glivec as a life-saving, breakthrough drug for certain forms of cancer, with patents granted in nearly 40 countries.”

The company effectively trumpets the line that its own science is singular, its own innovative practices unique.  The moral message of saving patients is emphasised.  “The ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options.”

Such a position entirely ignores the fact that the patent system is, in its own manner, abused to prevent innovation altogether.  A long standing fiction, one happily embraced by the pharmaceutical giants, is that a patent reflects innovative practices, a protection against marauding imitators who undermine the value of effective drugs.

In truth, it tends to reflect an economic sense of preventing rival companies from producing imitations at startlingly lower cost.  It is on that basis that the battleground in India has become so intriguing, and for patients keen on receiving a range of affordable drugs, exciting.

Binoy Kampmark was a Commonwealth Scholar at Selwyn College, Cambridge. He lectures at RMIT University, Melbourne and can be reached at: bkampmark@gmail.com. Read other articles by Binoy.